Arena Blog

Avoid Product Failures with Connected Requirements Management

In 2017, the U.S. Food & Drug Administration (FDA) issued 500
recalls of medical devices and/or parts of medical devices. Fifty-two of these
recalls were identified as Class I: a class reserved for a situation where
there is a reasonable chance a product will cause serious health problems or
death [i].
So far in 2018, the FDA has already identified 64 Class I recalls, including
resuscitation masks for infants, implantable cardioverter defibrillators
(ICDs), and inhalation anesthesia machines. Capturing, defining, and delivering
solutions that address requirements is key to prevent product delivery and quality issues.

Requirements management is the continuous and
iterative process enabling stakeholders to collect, document, analyze,
prioritize, and agree upon the requirements while managing changes as product
development evolves. In some industries—such as consumer electronics and medical device—the
development and production of a single product involves a multitude of parts,
interdisciplinary team collaboration, and adherence to government regulated
standards. With medical devices, there is less room for error since the
consequences may include bodily harm or even death should a product fail.

Whether you deliver complex medical devices or other products, it’s
critical to avoid product issues or failures to prevent risks to your customers
and ensure their continued satisfaction with your product. Consider these six requirements management
lessons from recent medical device recalls.

1. Do your research. While
the English axiom is “Measure twice, cut once,” the Russian proverb advises:
“Measure seven times, cut once.” Requirements management often necessitates
extensive research up-front, particularly for new products and processes.
Consider the ongoing case of the Olympus Corporation medical scope that was linked
to an infectious outbreak resulting in at least 35 deaths[ii].
A Seattle judge recently cited Olympus Corporation for failing to disclose
internal emails that revealed a prototype of the scope was criticized for not
being easy to clean [iii].
Think of time spent doing research and feasibility studies as a wise investment—one
with the possibility of a seven-fold return.

2. Directly engage indirect
stakeholders. Identifying and engaging with supply chain partners, such as
parts suppliers and contract manufacturers, can help eliminate sourcing issues,
design errors, and manufacturing problems. In many of these cases, device
failure is caused by only one part. Take, for example, last year’s FDA recall
of the Philips Respironic V60 ventilators: pins loosened during vibrations
prevented data transfer, resulting in unexpected shutdowns[iv].
While it may not be feasible to directly engage all indirect stakeholders at
every single step in product development, providing partners with a way to see
the big picture and emphasizing the importance of their roles is essential.

3. Assign responsibility. Depending
upon your industry and organization, the requirements management process may be
spread out across diverse teams, including engineering, product, and marketing.
Ideally, one person—such as a business analyst or product manager—oversees the
entire process, but that kind of oversight can be difficult in today’s world. As
an alternative, consider having each team assign ownership to one
representative so that he or she can act as a liaison as requirements are reviewed,
modified, prioritized, and negotiated.

4. Ensure traceability. Traceability
improves when you connect product requirements directly to your product record
(parts, assemblies, or lines of code). As the design evolves from early concept
through feasibility studies and testing­, teams need to be able to trace
requirements to design decisions and business objectives. Whether your
organization favors waterfall or agile methodologies, traceability means you
can follow the life of your product both backwards and forwards to see how
high-level requirements impact low-level requirements and vice versa.
Traceability is especially important when you’re creating products that
potentially pose risks. Increasingly, in the medical device industry, software
has been a leading cause of product failures and recalls, particularly for
devices that are connected to the Internet of Things (IoT) and, therefore, more
vulnerable to hacking [v].

5. Establish a baseline. Your
product development cycle may be three months or more, but you need to
establish a baseline and traceability to keep all teams and partners aligned.
Though milestones can shift due to roadblocks beyond your control, creating a cross-functional
requirements review process with internal teams and external partners
establishes a baseline of accountability and increased transparency. Connecting
requirements to the product design record also provides better traceability should
stakeholders change their minds and introduce different requirements that may postpone
or derail a product launch.

6. Agree on a communication
strategy. George Bernard Shaw wrote, “The single biggest problem in
communication is the illusion that it has taken place.” As Shaw wisely
observed, the illusion of communication can be a prodigious pitfall. Whatever
communication and collaboration tools you decide to use, explicitly agreeing
upon how and when you will use them, maintaining regular meetings (even if
they’re virtual and/or check-ins), and including stakeholders in the discussion
will help to make certain communication takes place.

On average, recalls cost the medical device industry $2 to $5 billion
each year [vi].
Beyond these substantial fiscal costs for the industry, federal insurance
programs, such as Medicare, and private insurers shoulder a large part of the
financial burden for recalls while patients pay up-front or out-of-pocket
costs, including travel time to and from specialists. More importantly, some
medical device failures and subsequent recalls may reduce the quality of life
or even result in death.

Clearly, ensuring quality and compliance is essential not only to your
product’s success, but also to your reputation and the well-being of your
customers. There are many reasons for product recalls, but avoiding recalls
starts with effective requirements management. This requires
connecting requirements to product design to ensure traceability throughout the
product lifecycle. So, consider addressing requirements early in the product
development process to help deliver products that not only change the world but
may also save lives.

Footnotes

Class II describes a product that may cause a temporary or reversible
health problem or a situation where there is a slight chance a product will
cause serious health problems or death; Class III applies to a product that is
not likely to cause any health problem or injury [1].